Registering “Applicable Trial” Data on ClinicalTrials.gov Managing Disclosure of Negative or Non-significant Results
Product Details
An FDAnews
Webinar Rebroadcast
You have spoken – and we’re responding. By popular demand, FDAnews is rebroadcasting this best-selling event for clinical trials sponsors.
It’s your best opportunity – and last chance – to attend this very highly rated event.
Nearly 600 people attended this invaluable webinar the first time around. Here’s what two of our satisfied registrants had to say:
“I heard about ClinicalTrials.gov but didn't know the details of it. After attending this seminar, I have a better understanding of the criteria for registering a clinical study, clinical registry and result registry.”
— Minghua Grisell, Clinical Data Manager, W. L. Gore & Associates, Inc.
“The speaker was very knowledgeable and was able to answer questions in detail.”
— Michelle Castaneda, Clinical Research Associate, St. Jude Medical
Three little words, “applicable clinical trial.” How have they become so difficult to understand when it comes to registering trials on ClinicalTrials.gov?
With reports of industry “cherry picking” on the rise — and new rules currently in development — now’s the time to get expert guidance.
While the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that sponsors and clinical investigators register all applicable clinical trials and report the results of these trials on the National Institutes of Health’s (NIH’s) ClinicalTrials.gov website, many are accused of “cherry-picking” and only reporting positive trial outcomes.
Yet, is it cherry picking or confusion on what constitutes an applicable clinical trial?
Regardless of your answer, the NIH, FDA and OIG are ramping up enforcement of the requirements and are increasing pressure on firms to report all applicable clinical trials. In 2010 three firms were mandated to comply with registration and reporting requirements through OIG corporate integrity agreements.
It’s a looming crisis for the clinical trials community. Fortunately, help is at hand.
FDAnews has invited a leading authority, attorney Scott Cunningham, to offer a sneak peek at the new rules, plus just-in-time guidance on how you can manage your submissions.
Mark your calendar for Thursday, March 29, when we’ll rebroadcast Mr. Cunningham’s webinar from January that focused on the new essentials of reporting. In 90 fast-paced minutes, you’ll discover:
- What the FDAAA says, and how its provisions impact your clinical trials;
- Current status of the proposed FDAAA 801 rulemaking;
- Best practices to manage disclosure of negative or non-significant results;
- Avoiding mistakes when applying the regulatory exemptions;
- Strategies to assure compliance with the potentially conflicting requirements of ClinicalTrials.gov, state and international agencies;
- Untangling FDAAA clinical trials disclosure requirements;
- How to avoid overstepping the 12-month deadline for applicable clinical trials;
- Reassessing audit and monitoring processes for results posting;
- And much more.
Like every FDAnews webinar, Registering “Applicable Trial” Data on ClinicalTrials.gov is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your home office.
Everyone in your organization with a role in clinical trials deserves to take part in this event — and they can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.
Why risk fines, penalties or worse, when preparing for these new reporting rules could be so painless? Don’t wait another minute. Register now.